Bio Process Development

Bio Process Development

November 18th, 2019 by

Description of Role

We are currently seeking an experienced, creative, and highly motivated Process Developer to build in-house manufacturing capabilities including but not limited to: innovative systems, building a team, and identifying and removing barriers to efficient production of complex communities of anaerobic microbes. This person would be responsible for the overall bioprocess development and implementation strategy in collaboration with the research team including a role in influencing research direction and strategies for strain selection. Additional responsibilities include hands on process development around the early research grade and GMP material. A core focus is the ability to rapidly develop processes to culture, purify, and combine diverse anaerobic bacteria for therapeutic use. This process developer will play a critical role in the development of novel microbiome therapeutics to support the development of exciting new therapies across a variety of diseases.

Core responsibilities and opportunities are:

  • Design and development of internal scalable fermentation processes for a variety of anaerobic microbial strains
  • Manufacturing master cell banks, combined communities, and final drug product in an early phase GMP environment
  • Setting appropriate release specifications for the components of the drug substance as well as the final drug product
  • Identifying and qualifying analytical methods in order to ensure the delivery of quality products for dosing
  • Authoring CMC sections of briefing books and/or other submissions (e.g. IND) for regulatory authorities
  • Preparing media, buffers, single-use components for GMP use
  • Operating and maintaining small-scale process equipment
  • Ordering and inventorying raw materials
  • Coordinating 3rd party contractors and vendors as needed
  • Collaborate with experimental biologists to design well-controlled experiments, develop best practices for strain growth and characterization
  • Communicate clearly, work independently, collaborate heavily, think critically

Key Qualifications

PREFERRED:

  • Extensive experience with bioprocess development of anaerobic microbes or other types of cultures
  • Experience in media optimization and developing scalable downstream production processes
  • Authorship of early phase CMC regulatory submissions for products containing live bacterial products (LBP)
  • Familiarity with LBP FDA regulations and GMP standards
  • Advanced and applied mathematics for process modeling, network analysis, metabolomics
  • Proven track record for rapid development, IP innovation, and scale-up for early-phase biologics

MINIMAL:

  • BS preferably in chemical or bioengineering, mechanical engineering, or related technical discipline
  • At least 4 years of hands-on experience in early process development
  • Direct experience with microbial cell banking, cell culture, fermentation

 

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